Lupin, on 23 November, announced that it had received approval from the USFDA (United States Food and Drug Administration) for Canagliflozin Tablets, 100 mg and 300 mg. The drug will be manufactured at the company’s Pithampur facility.

The Canagliflozin Tablets, 100 mg and 300 mg are generic equivalents to Invokana Tablets, 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc.

In its regulatory filing, the company said, “Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease and to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death and hospitalisation for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria.”

The Canagliflozin Tablets for the reference listed drug (RLD Invokana had an estimated annual sales of $561 million in the US according to IQVIA MAT September 2023 data.